Compliance and Quality Specialist at IQVIA - Kuala Lumpur

The Compliance and Quality Specialist is responsible for ensuring a comprehensive quality and compliance approach for clinical trials. This role collaborates with both local and global quality functions to monitor compliance risks and support audits and inspections.

In this role, you will engage in day-to-day activities that involve monitoring compliance and performing quality control checks within clinical trials. You will also manage local procedures and provide expertise on regulatory intelligence and standard operating procedures.

Key Responsibilities:

• Monitor compliance risk and perform quality control checks.
• Support audits and inspections to ensure adherence to regulations.
• Manage local procedures and documentation related to clinical trials.
• Provide expertise and guidance on SOP, GCP questions, and regulatory intelligence.
• Collaborate with local and global quality functions to enhance compliance strategies.
• Facilitate Root Cause Analysis and development of CAPA.
• Lead projects to drive compliance productivity and process improvements.